RecruitingNot ApplicableNCT04363983

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

6,300 participants

Start Date

Jan 13, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Blood sampling, a procedure called Liver biopsy, and others for people with gastrointestinal neoplasms. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBlood sampling

Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Following analysis should be performed with * serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...; * plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics; * PBMC for flow cytometry analysis, isolation macrophages; * whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells.

PROCEDURELiver biopsy

An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients. This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time. This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed.

BIOLOGICALStool collect

Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Analysis will be performed for microbiota and metabolism analysis.


Locations(1)

Digestive Surgery Department, Ambroise Paré Hospital, APHP

Boulogne-Billancourt, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04363983


Related Trials